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8-K - FORM 8-K - HUMAN GENOME SCIENCES INC | c10742e8vk.htm |
EX-99.2 - EXHIBIT 99.2 - HUMAN GENOME SCIENCES INC | c10742exv99w2.htm |
Exhibit 99.1
PRESS RELEASE
Media Contacts:
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Investor Contacts: | |
Jerry Parrott
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Claudine Prowse, Ph.D. | |
Vice President, Corporate Communications
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Executive Director, Investor Relations | |
301-315-2777
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301-315-1785 | |
Susannah Budington
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Peter Vozzo | |
Director, Corporate Public Relations
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Senior Director, Investor Relations | |
301-545-1062
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301-251-6003 |
HUMAN GENOME SCIENCES REPORTS PROGRESS TOWARD SUSTAINABLE REVENUES AND ANNOUNCES 2011 GOALS AT
JPMORGAN HEALTHCARE CONFERENCE
| President and CEO H. Thomas Watkins sets goal of multi-billion dollar annual revenues by 2015 |
| HGS well prepared for successful launch of BENLYSTA®, potentially the first approved drug for lupus in more than 50 years |
ROCKVILLE, Maryland January 10, 2011 Human Genome Sciences, Inc. (Nasdaq: HGSI) today will
announce its priority goals for 2011 and provide updates on the Companys progress toward becoming
a fully commercial organization with sustainable revenues and multiple opportunities to drive
future growth. The presentation will be made this afternoon by H. Thomas Watkins, President and
Chief Executive Officer, to financial analysts and investors at the 29th Annual JPMorgan
Healthcare Conference in San Francisco.
Based on the opportunities we have in hand and our expectation of U.S. and European regulatory
approvals of BENLYSTA, we believe HGS will achieve sustainable multi-billion dollar annual revenues
by 2015, said Mr. Watkins. 2011 will be a game-changing year for us assuming approval and launch
of BENLYSTA as the first new drug for lupus in over 50 years. HGS has systematically hired and
carefully trained a specialized
commercial team that we believe is second to none in their experience and familiarity with
rheumatology, biologics and infused products. We are ready to hit the ground running alongside
GlaxoSmithKline following FDA approval of BENLYSTA.
We are also fully committed to achieving the full therapeutic and commercial potential of BENLYSTA
by developing it for other B-cell mediated diseases where patients need new therapeutic options and
strong scientific evidence supports therapeutic potential and commercial viability, he added. In
2011, we plan to initiate Phase 2 trials of BENLYSTA in vasculitis and post-renal transplant, as
well as a Phase 3 trial of a subcutaneous formulation of BENLYSTA.
Mr. Watkins added that HGS will continue to invest strategically in its oncology and other pipeline
opportunities. These strategic investments are made possible by a strong financial position that
we view as essential to our ability to achieve sustainable revenues and sustainable growth into the
future, he said.
During his presentation, Mr. Watkins will discuss the following goals and updates on progress:
BENLYSTA® for Systemic Lupus Erythematosus (SLE): Target Date for FDA Decision on U.S. Approval
March 10, 2011; Specialized HGS Commercial Team Hired and Trained; European Regulatory Decision
Anticipated Second Half 2011; Building European Organization to Work Alongside GSK in Key Countries
On November 16, 2010, the FDA Arthritis Advisory Committee voted 13-2 to recommend that the FDA
approve BENLYSTA (belimumab) for the treatment of autoantibody-positive patients with active SLE
who are receiving standard therapy. Following the Advisory Committee meeting, the FDA requested
additional information from HGS, which the Company has submitted. In December 2010, the FDA
extended the Prescription Drug User Fee Act (PDUFA) target date for the priority review of BENLYSTA
to March 10, 2011.
BENLYSTA is an investigational drug and the first in a new class of drugs called BLyS-specific
inhibitors. HGS and GSK are developing BENLYSTA under a definitive co-development and
co-commercialization agreement entered into in 2006.
In preparation for the successful launch and commercialization of BENLYSTA assuming regulatory
approval, HGS has systematically hired and trained a specialized team including sales, marketing
and medical affairs. The combined HGS and GSK team, including a U.S. sales force of approximately
150, will work closely together following
approval to communicate effectively and appropriately with rheumatologists and other stakeholders
and ensure that appropriate patients with systemic lupus who need BENLYSTA will have access to it.
HGS and GSK also plan to support physicians and patients with reimbursement and access programs.
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Under the terms of the 2006 co-development and co-commercialization agreement with GSK, HGS has
responsibility for the global supply of BENLYSTA upon receiving regulatory approvals. HGS
currently has inventory available to meet global market needs for at least one year, and its
large-scale manufacturing facility has sufficient capacity to provide worldwide supply for the
first two to three years following launch. However, HGS and GSK also anticipate that additional
capacity will be required. In July 2010, HGS announced an agreement with Lonza that will provide
for the future commercialization of BENLYSTA, eventually tripling capacity with production coming
on line in 2012.
HGS and GSK expect to receive European approval of BENLYSTA in the second half of 2011. GSK has
also submitted regulatory applications in Canada, Australia, Switzerland, Russia and Brazil.
Regulatory submissions in other countries are planned in 2011. HGS is building its own
commercialization team to work alongside GSK in Europe, with headquarters in Switzerland and local
organizations in Germany, France and Spain. Elsewhere, GSK will lead local implementation, with
HGS sharing costs and profits equally with GSK.
Key goals for BENLYSTA in 2011:
| FDA approval and U.S. launch. |
| European approval and launch. |
| Initiate Phase 3 trial of subcutaneous formulation. |
| Initiate Phase 2 trials in vasculitis and post-renal transplant. |
Raxibacumab: Deliveries to U.S. Strategic National Stockpile Continue under Second BARDA Contract
In July 2009, the U.S. Government exercised its option to purchase an additional 45,000 doses of
raxibacumab for the U.S. Strategic National Stockpile for emergency use in treating inhalation
anthrax, with delivery to be completed over a three-year period. HGS expects to receive
approximately $142 million from this second award as deliveries are completed, including
approximately $51 million received in 2010.
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Raxibacumab is being developed under a contract entered into in 2006 with the Biomedical Advanced
Research and Development Authority (BARDA) of the Office of the Assistant Secretary for
Preparedness and Response (ASPR), U.S. Department of Health
and Human Services (HHS). HGS continues to work closely with FDA to achieve licensure of
raxibacumab. HGS is entitled to receive $20 million under its contract with the U.S. Government
upon FDA licensure.
Key goals for raxibacumab in 2011:
| Deliver 15,000 doses to the U.S. Strategic National Stockpile and receive approximately $50 million in revenue as deliveries are accepted. |
| Continue to work with the FDA to achieve licensure of raxibacumab. |
Mid- and Early-Stage Pipeline: A Primary Focus on Immunology and Oncology
HGS is investing strategically to expand and advance its mid- and early-stage pipeline beyond
potential additional indications for BENLYSTA, with a primary focus on immunology and oncology.
The Company is developing its oncology portfolio around its expertise in the apoptosis, or
programmed cell death, pathway, and also plans to initiate Phase 2 development of its human
monoclonal antibody to the CCR5 receptor for the treatment of ulcerative colitis.
Mapatumumab, a human monoclonal antibody to TRAIL receptor 1, is currently being studied in
combination with Nexavar (sorafenib) for the treatment of advanced hepatocellular cancer.
Ongoing Phase 1 trials are evaluating HGS1029 as monotherapy in patients with advanced solid and
advanced lymphoid tumors. HGS1029 is an IAP inhibitor, a novel class of compounds that block the
activity of IAP (inhibitor of apoptosis) proteins, allowing apoptosis to proceed and causing the
cancer cells to die. When IAP proteins are over-expressed in cancer cells, they can help cancer
cells resist apoptosis and resume growth and proliferation. HGS plans to continue the study of
HGS1029 both alone and in combination with other anti-cancer agents, including mapatumumab.
Key goals for the HGS mid- and early-stage pipeline in 2011 are:
| Continue the clinical trial of mapatumumab with sorafenib in advanced hepatocellular cancer. |
| Initiate Phase 1b oncology studies of HGS1029 in combination with mapatumumab and other agents. |
| Complete Phase 1 trials of HGS1029 as monotherapy in advanced solid and lymphoid tumors. |
| Initiate Phase 2 trial of CCR5 mAb in ulcerative colitis. |
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GSK Pipeline: Two Phase 3 Trials of Darapladib Ongoing for the Treatment of Cardiovascular Disease;
Eight Phase 3 Trials of Albiglutide Ongoing for the Treatment of Type 2 Diabetes Mellitus
In two pivotal Phase 3 trials, GSK is currently evaluating whether darapladib can reduce the risk
of adverse cardiovascular events such as heart attack or stroke in patients with chronic coronary
heart disease and acute coronary syndrome, respectively. With a planned enrollment of more than
27,000 patients in the two trials, the Phase 3 clinical program for darapladib is among the largest
ever conducted to evaluate the safety and efficacy of any cardiovascular medication. Darapladib
was discovered by GSK based on HGS technology. HGS will receive 10% royalties on worldwide sales
if darapladib is commercialized, and has a 20% co-promotion option in North America and Europe.
GSK now has eight Phase 3 trials in progress to evaluate the long-term efficacy, safety and
tolerability of albiglutide as monotherapy and add-on therapy for patients with type 2 diabetes
mellitus. Albiglutide was created by HGS using its proprietary albumin-fusion technology, and the
product was licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could
amount to as much as $183 million including $33 million received to date in addition to
single-digit royalties on worldwide sales if albiglutide is commercialized.
2010 Financial Guidance
HGS expects cash and investments at year-end 2010 to total between $900 million and $950 million.
Cash and investments were approximately $1.2 billion at the end of 2009, which included net
proceeds from successful public offerings of HGSI common stock.
Presentation to Be Webcast
Mr. Watkins presentation to the 29th Annual JPMorgan Healthcare Conference will be
webcast and may be accessed at www.hgsi.com. The presentation is scheduled to begin on January 10,
2011, at 3:30 PM Pacific or 6:30 PM Eastern time. Investors interested in listening to the live
webcast may want to log on before the presentation begins to download any software required. The
archive of the presentation will be available for several days following the event.
About Human Genome Sciences
Human Genome Sciences exists to place new therapies into the hands of those battling serious
disease.
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For more information about HGS, please visit the Companys web site at www.hgsi.com. Health
professionals and patients interested in clinical trials of HGS products may inquire via e-mail to
medinfo@hgsi.com or by calling HGS at (877) 822-8472. HGS, Human Genome Sciences and BENLYSTA are
trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their
respective owners.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. The forward-looking statements are based on Human Genome Sciences current intent, belief
and expectations. These statements are not guarantees of future performance and are subject to
certain risks and uncertainties that are difficult to predict. Actual results may differ materially
from these forward-looking statements because of Human Genome Sciences unproven business model,
its dependence on new technologies, the uncertainty and timing of clinical trials and regulatory
approvals, Human Genome Sciences ability to develop and commercialize products, its dependence on
collaborators for services and revenue, its substantial indebtedness and lease obligations, its
changing requirements and costs associated with facilities, intense competition, the uncertainty of
patent and intellectual property protection, Human Genome Sciences dependence on key management
and key suppliers, the uncertainty of regulation of products, the impact of future alliances or
transactions and other risks described in the Companys filings with the SEC. Existing and
prospective investors are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of todays date. Human Genome Sciences undertakes no obligation to
update or revise the information contained in this announcement whether as a result of new
information, future events or circumstances or otherwise.
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